Table 3.
Summary of particle therapy studies.
| Study | Nature | Number of Patients | Dose/Fractionation, Concurrent Chemotherapy | Outcomes | Toxicity (≥Grade 3) |
|---|---|---|---|---|---|
| Hong et al., 2014 [30] | Prospective; Neoadjuvant (Proton) | 50 | 25 Gy/5 fractions, Capecitabine | 11 patients did not have surgery, Out of 48 patients: PFS: 10.4 months, OS: 17.3 months, 2-year OS: 42%, Out of 37 patients who had surgery: PFS: 14.5 months, OS: 27 months |
Acute: colitis (1), chest wall pain (1) |
| Sachsman et al., 2014 [31] | Prospective; Definitive (Proton) | 11 | 59.4 Gy/33 fractions, Capecitabine | 2-year PFS: 14%, OS: 18.4 months, 2-year OS: 31%, 2-year FFLP: 69% |
None |
| Terashima et al., 2012 [32] | Prospective; Definitive (Proton) | 50 | P1: 50 Gy/25 fractions (5), P2: 70.2 Gy/26 fractions (5), P3: 67.5 Gy/25 fractions (40), All with concurrent gemcitabine |
Overall: 1-year PFS: 64.3%, 1-year OS: 76.8%, 1-year FFLP: 81.7%, P3 patients: 1-year PFS: 60.8%, 1-year OS: 78.8%, 1-year FFLP: 79.9% |
P1 and P2:, Acute GI bleeding (1), P3: GI ulcer treated with medications (3); death from GI bleed (1) |
| Shinoto et al., 2013 [28] | Prospective, Phase I, neoadjuvant (Carbon) | 21 | 30–36.8 GyE/5 fractions, No concurrent chemotherapy |
No local recurrence, 1-year PFS: 40%, 1-year OS: 69%, 5-year OS: 42%, Median OS: 18.6 months |
Acute: Liver abscess (1), Late: Deranged liver function due to portal vein stenosis (1) |
| Shinoto et al., 2016 [29] | Prospective, Phase I, LAPC (Carbon) | 71 | 43.2–55.2 GyE/12 fractions, Gemcitabine | 1-year OS: 73%, 2-year OS: 35%, Median OS: 19.6 months, Better outcomes in those who had ≥45.6 GyE |
Acute (non-hematologic): Anorexia (6), GI bleed (1) |